AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function

NCT07428967 | Recruiting

• 1 other identifier: AVA CONDUCT
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief Summary

AVA CONDUCT is a prospective, multicenter, randomized study with single blinding, comparing left bundle branch area (LBBA) pacing with right ventricular (RV) pacing following AV node ablation in terms of clinical, functional, and electrophysiological outcomes. The primary hypothesis is that pacing-induced cardiomyopathy, defined as a decrease in LVEF by 10% or more from baseline to an absolute value below 50%, occurs significantly more frequently in patients receiving RV pacing compared with LBBA pacing. Secondarily, LBBA pacing is expected to maintain comparable procedural safety while providing better cardiac function, resulting in improved quality of life and functional capacity compared with conventional RV pacing.

Conditions

Atrial Fibrillation; Atrial Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Number of patients developing pacemaker-induced cardiomyopathy

  Echocardiographically detected deterioration in systolic LVEF of ≥10% to an absolute value of \< 50%

  36 months

Secondary Outcomes (14)

• Left ventricular function

  36 months

• Left Ventricular Global Longitudinal Strain

  36 months

• Right ventricular function

  36 months

• Right ventricular function

  36 months

• Right ventricular function

  36 months

Study Arms (2)

Right ventricular pacing

ACTIVE COMPARATOR

Procedure: RV pacing

Left bundle branch area pacing

ACTIVE COMPARATOR

Procedure: LBBA pacing

Interventions

RV pacing PROCEDURE

RV apical pacemaker implantation prior to AV node ablation

Right ventricular pacing

LBBA pacing PROCEDURE

LBBA pacemaker implantation prior to AV node ablation

Left bundle branch area pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of symptomatic AF (EHRA IIb - IV) despite guideline-indicated medical or interventional therapy
• Preserved LVEF (≥ 50%, assessed by echocardiography, Simpson's biplane method)
• AV node ablation scheduled independently of possible study participation
• Age ≥ 18 years
• Consent capacity

You may not qualify if:

• Impaired LVEF (\< 50%)
• Pre-implanted pacemaker
• Contraindication for pacemaker implantation or AV node ablation (see chapter 5.3 for details)
• High grade (III°) left cardiac valvular disease
• Surgical coronary revascularization (within the last 30 days) or current triple therapy after stent PCI
• Body-mass-index \> 40 kg/m2
• Pregnancy
• Inability to give written informed consent
• Life expectancy \< 12 months

Sponsors & Collaborators

• St. Josefs-Hospital Wiesbaden GmbH: lead

Study Sites (2)

Evangelisches Krankenhaus Hagen-Haspe

Hagen, Germany

NOT YET RECRUITING

St. Josefs-Hospital Wiesbaden GmbH

Wiesbaden, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 24, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)